Visitor Monitoring Drug History: DEXEDRINE
 
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Label and Approval History

Drug Name: DEXEDRINE
FDA Application No: (ANDA) 084935
Active Ingredient(s): DEXTROAMPHETAMINE SULFATE
Company: GLAXOSMITHKLINE
 
Label History
 
Labels are not available on this site for DEXEDRINE, (ANDA) 084935
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
11/28/2000 021Control Supplement  
2/24/2000 020Facility Addition  
10/27/1999 019Control Supplement  
7/30/1998 018Chemistry  
4/22/1997 016Labeling in Effect  
8/22/1991 015Labeling Expedite  
8/22/1991 014Chemistry Expedite  
5/17/1982 009Chemistry  
6/30/1982 008Chemistry  
2/26/1976 000Approval Other Important Information from FDA 
 
Therapeutic Equivalents
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